Andhra Pradesh Medical Services and Infrastructure Development Corporation (APMSIDC)
4th Floor, DM&HS Campus, Sultan Bazaar, Koti, Hyderabad- 500 095.
Phone: 040- 24658702/ Fax: 040-4738971
Website: http://apmsidc.ap.nic.in
T.No.11/APMSIDC/Medicine Wing/2016-18, Dt.28.11.2016
E-BID FOR THE EMPANELMENT OF ANALYTICAL TESTING LABORATORIES FOR ANALYSIS OF MEDCIINES, SURGICAL & CONSUMABLES FROM DCA APPROVED & NABL ACCREDITED TESTING LABORATORIES
For Two Years (Ending on 31.03.2019)
LAST DATE OF SUBMISSION OF ONLINE BIDS: 10.04.2017 , before 3PM.
Notice Inviting E-Bids
E-bids are invited up to 10. 04. 2017, before 3PM from DCA approved & NABL Accredited Testing Laboratories for Analysis of Medicines, Surgical & Consumables situated in India Details may be seen in the Bidding Documents at our office or at the website of https://tender.apeprocurement.gov.in may be downloaded from there.
Managing Director
APMSIDC
Andhra Pradesh Medical Services and Infrastructure Development
Corporation (APMSIDC)
E-BID FOR THE EMPANELMENT OF ANALYTICAL TESTING LABORATORIES FOR THE TEST AND ANALYSIS OF MEDICINES, SURGICAL & CONSUMABLES
(Ending on 31.03.2019)
Bid Reference : TNo.11/APMSIDC/Medicine Wing
/2016-18, dt: 28.11.2016.
Pre- bid conference : 03.04.2017 at 03.00 P.M.
O/o Managing Director, APMSIDC
Date and time for downloading : From 24.03.2017
bid document up to 10.04.2017 ,12:00 Noon
Last date and time for : 10.04.2017 at 3.00 PM
Uploading of bid document
Date and time of opening of : 10.04.2017 at 3.30 PM
Online technical bids
Last date and time of submission : 11.04.2017 at 5.00 PM
Of offline bids
Tender Processing Fee : Rs. 5,625/-
EMD : Rs. 2,00,000/-.
Transaction Fee to APTS (Online) : Rs. 2,000/-
Andhra Pradesh Medical Services and Infrastructure Development
Corporation (APMSIDC)
E-BID FOR THE EMPANELMENT OF ANALYTICAL TESTING LABORATORIES FOR THE TEST AND ANALYSIS OF MEDICINES, SURGICAL & CONSUMABLES
(Ending on 31.03.2019)
1. LAST DATE FOR RECEIPT OF BIDS, BID FEES, EMD, PROCESSING FEES AND EMPANELMENT FEES
a) E-Bids one Bid (Technical Bid) Will Be Received Till 3.00 PM on 10.04.2017 By Andhra Pradesh Medical Services and Infrastructure Development Corporation (APMSIDC), For The Empanelment Of Analytical Testing Laboratories for The Test And Analysis Of Medicines, Surgical & Consumables (Ending on 31.03.2019).
b) The bids shall be valid for a Period of 120 days from the date of opening of Technical Bid and prior to the expiration of the bid validity the Bid Inviting Authority may request the Bidders to extend the bid validity for another period of 30 days. The Bidder may refuse extension of bid validity without forfeiting the Earnest Money deposit.
c) i) The e-Bids will be received on web-portal of e-procurement of https://tender.apeprocurement.gov.in
ii) The Bid form can be downloaded from the website, (free of cost).
iii) Tender processing fee of Rs.5,625/- should be paid in the form of DD in favour
of MD, APMSIDC, taken on any scheduled bank.
iv) EMD of Rs.2,00.000/- should be paid in the form of DD in favour of MD,
APMSIDC, taken on any scheduled bank.
v) Transaction fee :-All the participating bidders have to electronically pay a non-refundable transaction fee to M/s APTS, the service provider through “Payment Gateway Service on E-Procurement platform”, as per the Government Orders placed on the e-procurement website.
vi) All the document uploaded in online shall be submitted offline before 11.02.2017 @ 5.00PM
2 Eligibility Criteria for Empanelment:-
(1) Medicine Testing Laboratories should have valid Approval for carrying out test on drugs under the Drugs and Cosmetics Act, 1940 and Rules there under, with three years standing in the test analysis and the lab shall be entitled for empanelment for the categories of items for which lab is having approval. Bid is invited from approved Drugs Testing Laboratories situated in India.
(2) The laboratory should be GLP compliant under the provisions of Drugs and Cosmetics Act, 1940 and Rules there under and should hold schedule L1 certificate or should have NABL accreditation with proper scope of accreditation to undertake testing of drugs, surgical and sutures.
(3) The laboratory should have an average annual turnover of not less than Rs. 50 lakhs towards drug, surgical, sutures and Larvicides Insecticides testing services for past preceding three years (2013-14, 2014-15, 2015-16 ) (Annexure.I) For turnover, CA certificate to be submitted confirming turnover for testing facilities i.e. purchase of reference standards, testing reagents and testing invoices.
(4) The lab should have undertaken test and analysis of drugs and supplies of similar nature of at least three government institution/corporation/reputed manufacturers of drug formulations.
(5) The lab should not stand banned / debarred or blacklisted by any State or Central Government Organizations or its central procurement agencies on the due date of bid submission.
(6) The laboratory should not have been convicted under the provisions of applicable laws with regard to the activities and conduct of the laboratory (Latest Non- Conviction Certificate issued by the State Licensing Authority/ competent authority in the last six months to the tendering date)
(7) The laboratory should have all necessary instruments/equipments/machines for testing of drugs.
3 TECHNICAL BID
The Bidder must furnish the following in technical bid.
Bidders are allowed the option to quote for anyone item or more items as mentioned in bid (list of medicines and surgicals proposed to be testing at Annexure- VII & VIII). The bidder has to mention the type of test for each item to be carried out by him. The filled up annexure VII &VIII to be submitted with Technical bid.
The bidders shall submit/upload scanned copies of all the D.D ‘s for processing fee and Earnest Money. The required EMD and processing fee shall be in the form of D.D drawn separately in favor of M.D. APMSIDC.
(a) Attested Photocopy of Analytical Testing License (approval) duly renewed up to date and issued by the Licensing Authority.
(b) Compliance of Schedule L-1 of Drugs Cosmetics Rules, 1945 (GLP certificate)/Copy of NABL accreditation with scope for testing of drug formulations.
(c) Documentary evidence of having analyzed Drugs for the last three years with a statement in the proforma as given in Annexure II.
(d) Attested copy of certificate of registration for service tax.
(e) Latest Non- Conviction Certificate issued by the State Licensing Authority/ competent authority in the last six months to the tendering date.
(f) Annual turnover statement for 3 years i.e. 2013-14, 2014-15 and 2015- 16 certified by the practicing Chartered Accountant.( Annexure I) pertaining to the purchase of reference standards, testing reagents and testing invoice only.
(g) Copies of the Balance Sheet and Profit and Loss Account for three years 2013-14, 2014-15 and 2015-16 duly certified by the practicing Chartered Accountant. Containing the details of purchase of reference standards, testing reagents and testing invoices.
(h) The following information in the form given in Annexure III (a) to III (d).
a) The list of qualified personnel employed in the laboratory with proof of their qualifications and relevant approvals.
b) The list of sophisticated instruments available in the laboratory.
c) Micro Biological facilities available in the laboratory.
d) List of Reference Standards along with their date of procurement and quantities.
e) In the case of Non- Pharmacopoeia Products the Method of Analysis Should be appended to the Report, especially if the sample is declared
as “Not of standard quality”.(NSQ)
f) A declaration in the proforma given in Annexure IV duly signed and notarized.
g) Details of Laboratory in Annexure – V.
h) A copy of PAN issued by Income Tax Department
i) Documentary evidence for the constitution of the company / concern
Bidder cannot be an individual or group of individuals or proprietorship firm.
4 PRICE BID:
The price bid will also be known as financial document and every bidder will be required to submit its price in excel format attached to the bid document (BOQ). BOQ template must not be modified/ replaced by the bidder and the same should be uploaded after filling the relevant columns, else the bidder is liable to be rejected for this bid. The bidder should quote rate for the complete tests as applicable to the item. The rate for sterility test for sterile products should also be quoted separately at last entry of BOQ.
5 OPENING OF TECHNICAL AND FINANCIAL EVALUATION
There after the Bidders found eligible as stated above on the basis of the examination of technical bid, the financial bid will be opened and after scrutiny thereof, including inspection of the laboratory, if required, the acceptable rates for analysis will be decided and communicated.
6 EARNEST MONEY DEPOSIT
The Earnest Money Deposit shall be Rs. 2,00,000/- (Rupees two lacksonly).The Earnest Money Deposit shall be paid through D.D in favor of M.D. APMSIDC and submit physically in the office of APMSIDC by 5.00 PM on 11.04.2017 Earnest Money Deposit in any other form will not be accepted.
The Bids submitted without sufficient EMD will be summarily rejected. The EMD will be forfeited, if the Bidder withdraws its Bid after last time & date fixed for receiving bids or in the case of a successful Bidder, if the Bidder fails
within specified time to sign the contract agreement or fails to furnish the security deposit.
7 GENERAL CONDITIONS
1. The details of the Medicines, Surgical & Consumables, to be analyzed shall be given in Annexure VII & VIII
2. The Bidder should quote the rates for complete analysis of each product and name
of test to be performed, methodology to be used for each test should be mentioned in Annexure-VII. However wherever rates for individual test are demanded, they should be furnished accordingly in BOQ. Wherever test is prescribed and their name and methodology for testing are not stated, such lab will not be considered responsive testing for such item.
3. The rates quoted should be inclusive of all taxes.
4. The rates quoted and accepted will be binding on the Bidder for the stipulated
period and on no account any revision will be entertained till the completion of
the BID period.
5. Analytical Laboratory, which also has its manufacturing activity, if empanelled by APMSIDC, then Samples of its own manufacturing unit shall not be sent to its empanelled laboratory for testing, if part of APMSIDC supply.
6. The laboratory will not be permitted to outsource any test from other laboratory.
7. APMSIDC shall have the right to cause the laboratory to be inspected by the members of its technical committee before opening of price bid and subsequently as and when considered appropriate and based on the finding, the Bidder may be disqualified or de-empanelled, as the case may be.
8. ACCEPTANCE OF BID
1. The Bid evaluation committee formed by Managing Director, Andhra Pradesh Medical Services Infrastructure Development Corporation will evaluate the Bid with reference to various criteria.
2. The Managing Director, APMSIDC reserves the right to accept or reject any BID for any one or more of the items Bided for, without assigning any reason.
9. AGREEMENT
1. The agreement with empanelled laboratories will remain valid up to 31.03.2019. This may be further extended for a further period with mutual consent.
2. All Bidders who are empanelled will have to execute an agreement on a non- judicial stamp paper of value Rs. 100 /- (Stamp duty to be paid by the Bidder), in favor of Managing Director, Andhra Pradesh Medical Services Infrastructure Development Corporation, within 15 days from the date of receipt of the intimation to them informing that their BIDs have been accepted. The form of agreement will be issued by APMSIDC.
3. The Bidder shall not, at any time, assign, sub-let or make over the contract or the benefit therefore or any part thereof to any person or persons whatsoever.
4. All notices or communication relating to, or arising out of this agreement or any of the terms thereof shall be considered duly served on or given to the Bidder if delivered to him or left at the premises, places of business or abode.
10. PERFORMANCE SECURITY
1. The successful Bidders shall be required to pay a security deposit of Rs.5,00,000/- in the form of demand draft at the time of execution of the agreement as Performance security. Performance security will be refunded three months after the expiry of rate contract subject to successful completion of services.
11. COMPLETE ANALYSIS REPORTING CONDITIONS
1. On empanelment and entrustment of the job, the Analytical Laboratory should furnish the test reports within:
I. 15 days from the date of receipt of the sample in case of Tablets, Capsules, Pessaries, Ointments, Powder and Liquid Oral Preparations (non – sterile products).
II. 28 days from date of the receipt of the sample in the case of I.V. Fluids and injectables and other items requiring test for sterility.
III. 28 days from the date of the receipt of the sample in the case of Surgical and Consumables.
b) All the tests mentioned in IP/BP/USP/Drugs Cosmetics Act. etc., (as the case
May be) should be carried out for each and every sample. The results obtained in the test should be mentioned in numerical value (wherever possible). However this condition will not apply when only specific testing is called for/desired on any particular sample.
c) “COMPLIES” or “PASSES” in the result column of the report is treated as
incomplete report, if the result has some numerical value.
d) Every test report must have remarks either as “Standard Quality” or “Not of Standard Quality”. Any ambiguity/cutting in reports will not be accepted (clear mention of “standard quality or not of standard quality” should be stated in bold letters and crossing/cutting of one of these will not be accepted).
e) Reports should be in A4 size (8.27” X 11.69”) paper of good quality.
f) Report should be issued on form 39 and should have S. no. , name of drug sample, code no., batch no., mfg. date, exp. date, description of tests, protocol of test specified applied, findings results obtained and should be signed by person-in-charge of testing. In case of Not of Standard Quality Reports the final results and reason for failure should be highlighted by pink / red highlighters.
g) Reports should be attached along with Spectra / Chromatography data sheets, if applicable and it will be considered incomplete if spectra or chromatograms are not attached.